Companion and Complementary Diagnostics
eBook - ePub

Companion and Complementary Diagnostics

From Biomarker Discovery to Clinical Implementation

  1. 508 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Companion and Complementary Diagnostics

From Biomarker Discovery to Clinical Implementation

About this book

Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies.- Covers all aspects, from biomarker discovery, to development and regulatory approval- Explains the "how to" aspects of companion diagnostics- Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

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Yes, you can access Companion and Complementary Diagnostics by Jan Trøst Jørgensen in PDF and/or ePUB format, as well as other popular books in Medizin & Pharmakologie. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Academic Press
Year
2019
Print ISBN
9780128135396
eBook ISBN
9780128135402
Topic
Medizin
Subtopic
Pharmakologie

Table of contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. List of Contributors
  6. Foreword
  7. Chapter 1. An Introduction to Companion and Complementary Diagnostics
  8. Chapter 2. The Drug-Diagnostic Codevelopment Model
  9. Chapter 3. Systems Biology in Biomarker Development for Cancer Signaling Therapy
  10. Chapter 4. Immunohistochemistry
  11. Chapter 5. In Situ Hybridization
  12. Chapter 6. Polymerase Chain Reaction
  13. Chapter 7. Next-Generation Sequencing–Based Companion Diagnostics: From Biomarker Discovery to Clinical Implementation
  14. Chapter 8. Current Next-Generation Sequencing–Based Companion Diagnostics and Their Analytical Validation
  15. Chapter 9. Companion and Complementary Diagnostics by Mass Spectrometry
  16. Chapter 10. Molecular Imaging Companion Diagnostics
  17. Chapter 11. Circulating Tumor DNA Analysis and Opportunities for Personalized Cancer Medicine
  18. Chapter 12. Companion Diagnostics Assay Development—Prototype, Verification, and Analytical Validation
  19. Chapter 13. Tissue Is the Issue: Challenges in Oncology Clinical Trial Tissue Sample Collection for Biomarker Analyses and Companion Diagnostics
  20. Chapter 14. Adaptive Trial Designs for Biomarker-Driven Clinical Trials With Quantitative and Multiple Candidate Biomarkers
  21. Chapter 15. Companion Diagnostics Based on Time-to-Event Data
  22. Chapter 16. Regulatory Requirements for Companion Diagnostics and Drug–Diagnostic Codevelopment in the United States
  23. Chapter 17. Companion Diagnostics and Biomarker Tests in the European Medicines Agency’s Assessment of Medicinal Products
  24. Chapter 18. Understanding the Current Regulatory Landscape for Companion Diagnostic Products in China
  25. Chapter 19. Regulatory Requirements for Companion Diagnostics—Japan
  26. Chapter 20. Economic Evaluation of Companion and Complementary Diagnostics
  27. Chapter 21. A Risk-Based Paradigm of Biomarkers in Clinical Trials
  28. Chapter 22. Implementing Companion Diagnostic Testing in the Clinic
  29. Chapter 23. Osimertinib (TAGRISSO™) and the cobas® EGFR Mutation Test v2
  30. Chapter 24. Quantitative Microsphere System Omecamtiv Mecarbil Immunoassay and Omecamtiv Mecarbil Codevelopment
  31. Chapter 25. Current Status and Future Direction of Companion Diagnostics
  32. Index